Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden’s bud­get wish list: Re­store the CDC, build a new NIH re­search cen­ter, pump in bil­lions to end the opi­oid and HIV epi­demics

Pres­i­dent Joe Biden’s first bud­get re­quest (Con­gress is the ul­ti­mate de­cider on bud­gets) for FY 2022 in­cludes a mas­sive in­flux of funds to the CDC, plans to launch a new $6.5 bil­lion re­search cen­ter with­in the NIH, as well as al­most $11 bil­lion to end the opi­oid epi­dem­ic and an­oth­er $670 mil­lion to ag­gres­sive­ly re­duce new HIV cas­es.

But de­tails on what ex­act­ly this new $6.5 bil­lion, DARPA-like, NIH-based cen­ter, to be known as Ad­vanced Re­search Pro­jects Agency for Health (ARPA-H), will re­search re­main to be seen. Biden’s bud­get re­quest on­ly said the cen­ter will ini­tial­ly fo­cus on a wide range of dis­eases that oth­er NIH cen­ters typ­i­cal­ly work on.

“With an ini­tial fo­cus on can­cer and oth­er dis­eases such as di­a­betes and Alzheimer’s, this ma­jor in­vest­ment in Fed­er­al re­search and de­vel­op­ment would dri­ve trans­for­ma­tion­al in­no­va­tion in health re­search and speed ap­pli­ca­tion and im­ple­men­ta­tion of health break­throughs,” the re­quest says.

At $6.5 bil­lion, the cen­ter will have about as much an­nu­al fund­ing as the Na­tion­al Can­cer In­sti­tute re­ceived in FY 2021. The funds are part of a $9 bil­lion re­quest­ed in­crease for NIH over­all.

Fol­low­ing the Trump ad­min­is­tra­tion’s sidelin­ing of the CDC, Biden’s dis­cre­tionary re­quest al­so in­cludes $8.7 bil­lion for the agency — a jump of $1.6 bil­lion over the 2021 en­act­ed lev­el, the largest bud­get au­thor­i­ty in­crease in near­ly two decades — to “re­store ca­pac­i­ty at the world’s pre­em­i­nent pub­lic health agency.” The new funds will help to mod­ern­ize pub­lic health da­ta col­lec­tion, train new epi­demi­ol­o­gists and oth­er pub­lic health ex­perts, and build in­ter­na­tion­al ca­pac­i­ty to de­tect, pre­pare for, and re­spond to glob­al pub­lic health threats.

In ad­di­tion, Biden al­so seeks an in­vest­ment of $10.7 bil­lion, an in­crease of $3.9 bil­lion over the 2021 en­act­ed lev­el, to sup­port re­search, pre­ven­tion, treat­ment, and re­cov­ery sup­port ser­vices re­lat­ed to the opi­oid epi­dem­ic. The ad­min­is­tra­tion said those funds will in­clude tar­get­ed in­vest­ments to sup­port those with unique needs, in­clud­ing Na­tive Amer­i­cans, old­er Amer­i­cans, and rur­al com­mu­ni­ties.

An­oth­er $670 mil­lion in the pro­pos­al for HHS will aim to help ac­cel­er­ate and strength­en ef­forts to end the HIV/AIDS epi­dem­ic in the US by in­creas­ing ac­cess to treat­ment, ex­pand­ing the use of pre-ex­po­sure pro­phy­lax­is, and im­prov­ing eq­ui­table ac­cess to ser­vices and sup­port.

Over­all, the pres­i­dent’s 2022 dis­cre­tionary re­quest in­cludes $131.7 bil­lion for HHS, which is a $25 bil­lion or 24% in­crease from 2021.

No­tably ab­sent in the bud­get re­quest is any de­tail re­lat­ed to the FDA’s bud­get. The re­quest mere­ly says the ad­min­is­tra­tion “would make in­vest­ments to en­hance FDA’s or­ga­ni­za­tion­al ca­pac­i­ty.” The FDA por­tion of the pres­i­dent’s full re­quest will like­ly in­clude more de­tail.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Sanofi, Cel­lec­tis team up to pair Lem­tra­da with al­lo­gene­ic CAR-Ts; Bris­tol My­ers joins Evotec's dri­ve to ad­vance UK sci­ence

Sanofi is partnering up with Cellectis on their allogeneic CAR-Ts.

Cellectis struck a deal to use the French pharma’s drug alemtuzumab (Lemtrada, an MS agent) as part of its lymphodepletion regimen — used to sideline host immune cells and improve CAR-T cell expansion and persistence.

The Sanofi drug is already used in some clinical trials, and now the pharma giant is on the hook for clinical studies as they engage in negotiations over a commercial pact. — John Carroll

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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